What are the benefits of conducting GMP audits and inspections?

1 What is GMP?

GMP stands for Good Manufacturing Practice, and it refers to a set of guidelines and principles that aim to ensure the quality and consistency of products that are intended for human or animal use. GMP covers all aspects of manufacturing, from the design and validation of facilities and equipment, to the selection and testing of raw materials, to the documentation and verification of procedures and records. GMP also requires regular audits and inspections, both internal and external, to monitor and evaluate the compliance and effectiveness of the quality system.

2 Why conduct GMP audits?

GMP audits are systematic and independent examinations of your manufacturing operations, to verify that they comply with the applicable GMP standards and regulations. They can be conducted by your own quality assurance team, by external auditors, or by regulatory authorities. The main benefits of conducting GMP audits include identifying and correcting any non-conformities or deviations that could compromise product quality or safety, improving processes and procedures, enhancing your quality culture, and demonstrating your commitment to quality and compliance. Furthermore, GMP audits can provide evidence and documentation of your compliance status and performance.

3 How to prepare for GMP audits?

GMP audits can be planned or unplanned, but it's important to be prepared for one regardless. To do this, you should review and update your quality system to make sure it's accurate and complete. Additionally, staff should be trained on GMP requirements and expectations, as well as their roles and responsibilities during the audit. Self-audits or internal audits should be conducted to identify any areas for improvement or correction, and corrective and preventive actions should be implemented accordingly. Finally, you should communicate and cooperate with the auditors by providing them with the necessary information and access, and responding to their questions and requests.

4 What to expect from GMP audits?

GMP audits typically follow a similar process, regardless of the auditor or the scope of the audit. This usually starts with an opening meeting to introduce the auditors, explain the objectives and scope of the audit, and agree on a schedule. Then, a document review will take place to examine your quality system documentation. Following that, a site inspection will be conducted to verify that your manufacturing facilities and equipment are in accordance with your documentation and GMP standards. During this time, an interview session will occur to check staff and managers' knowledge and understanding of GMP requirements. Finally, a closing meeting will be held to summarize the findings and observations, where you may receive a preliminary audit report including any non-conformities, observations, or recommendations.

5 How to follow up on GMP audits?

GMP audits are an integral part of the continuous improvement cycle, so it's important to follow up on the results and feedback. Review and analyze the audit report to understand any non-conformities or observations. Create a corrective and preventive action plan to address and resolve issues or gaps, and prevent them from recurring. Monitor and measure the effectiveness of your corrective and preventive actions, using quality indicators, customer feedback, or audit scores. Additionally, communicate and report your progress and achievements to auditors, regulators, and customers to demonstrate compliance and improvement. GMP audits are not only a requirement but a benefit for manufacturing operations. They help ensure product quality and safety, improve processes and performance, and enhance reputation and customer satisfaction. Thus, by conducting GMP audits regularly and effectively, you can achieve a high level of GMP compliance.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?